The superiority of once-daily Ultibro Breezhaler over twice-daily salmeterol/fluticasone in improving lung function2-3 and reducing the rate of COPD exacerbations4 has been established in previous studies. The FLASH study is the first randomised controlled trial to confirm the benefits of directly switching patients from this steroid-containing therapy to the dual bronchodilator1, therefore avoiding the side effects of the long-term use of inhaled corticosteroids. Critically, patients were switched without a wash-out period‡ to mimic clinical practice1.

These results further reinforce the latest GOLD recommendations, which support the use of dual bronchodilation for the majority of symptomatic COPD patients and limit the use of steroid-containing therapies to specific patient types5.

Importantly, the data released today also indicated that the safety and tolerability profiles of the two treatments were similar.

The FLASH study results were presented at the Asian Pacific Society of Respirology (APSR) Congress in Sydney, Australia (23-26 November 2017).

Vectura, a FTSE250 company listed on the London Stock Exchange (LSE: VEC), is an industry-leading device and formulation business for inhaled airways products offering a uniquely integrated inhaled drug delivery platform. With our extensive range of device and formulation technologies, integrated capabilities and collaborations, we are a leader in the development of inhalation products, increasing our ability to help patients suffering from respiratory diseases.

Vectura has eight inhaled, four non-inhaled and ten oral products marketed by partners with growing global royalty streams. The Group has a diverse portfolio of drugs in clinical development, including a number of novel and generic programmes which are partnered with several global pharmaceutical and biotechnology companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Bayer, Chiesi, Almirall, Janssen, Dynavax and Tianjin KingYork along with two wholly owned nebulised development programmes.

For further information, please visit Vectura's website at www.vectura.com.

About the FLASH study

The FLASH study is a randomized, multicenter, double-blind, double-dummy, parallel-group, 12-week treatment trial1. It involved a total of 502 moderate-severe, symptomatic and non-frequently exacerbating† patients with COPD1.

The primary objective of the study was to demonstrate the superiority of once-daily Ultibro® Breezhaler® 110/50 mcg compared with twice-daily salmeterol/fluticasone (50/500 mcg) in terms of improving lung function (trough pre-dose FEV1 at Week 12)1.

Secondary objectives of the study were to investigate the effect of Ultibro Breezhaler compared with salmeterol/fluticasone on6:

Transition Dyspnea Index (TDI) focal score at Week 12

Trough pre-dose forced expiratory vital capacity (FVC) at Week 12

COPD symptoms at Week 12 as measured by the COPD Assessment Test (CAT)

Mean rescue medication use (puffs/day) and percentage of days without rescue medication use over 12 weeks

The study also assessed the safety and tolerability over 12 weeks (including adverse events, serious adverse events and COPD exacerbations)1.

About Ultibro Breezhaler

Ultibro® Breezhaler® 110/50 mcg is a once-daily LABA**/LAMA††dual bronchodilator approved in the European Union (EU) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD7.Clinical trials have shown that it offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including salmeterol/fluticasone 50/500 mcg and open-label tiotropium (18 mcg)8-10. Ultibro Breezhaler is currently approved for use in over 90 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.

About the Novartis COPD portfolio

Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. The Novartis COPD portfolio includes Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide), Seebri® Breezhaler® (glycopyrronium bromide) and Onbrez® Breezhaler® (indacaterol), which are all indicated as maintenance treatments for COPD patients. Glycopyrronium bromide and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei and Vectura.

Novartis continues development of respiratory products for delivery via the low resistance Breezhaler inhalation device, which makes it suitable for patients with different severities of airflow limitation11. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly7,11.

About COPD

Chronic obstructive pulmonary disease (COPD) affects an estimated 210 million people worldwide12 and is the fourth leading cause of death13. It is progressive (usually gets worse over time) and can be a life-threatening disease5,12. COPD makes it difficult to breathe, with symptoms that have a destructive impact on patients' function (i.e. activity limitation, decreased mobility) and quality of life 5,12.

§ Seretide is a registered trademark of the GlaxoSmithKline Group of Companies

* Assessment of switching salmeterol/fluticasone to indacaterol/glycopyrronium in a symptomatic COPD patient cohort